Lupin gains on USFDA nod for body oil used in treating skin problems
This product will be manufactured at Lupins Somerset facility in the US. This medication is indicated for treating eczema, a skin condition that causes red, irritated, and itchy skin.
Shares of Lupin Ltd gained more than 2 per cent in morning trade on Wednesday after the pharma company announced that its subsidiary has received approval from the US Food and Drug Administration (USFDA) for Fluocinolone Acetonide body oil, which is used to treat skin problems.
In a filing to the stock exchanges on Tuesday, Lupin announced that approval for the body oil has been received by its wholly-owned subsidiary, Novel Laboratories Inc., based in Somerset, New Jersey, United States.
Lupin’s Fluocinolone Acetonide body oil applications
The new drug application for Fluocinolone Acetonide oil, 0.01 per cent, is a generic equivalent of DermaSmoothe 0.01 percent (body oil), of Hill Dermaceuticals Inc.
This product will be manufactured at Lupin's Somerset facility in the US.
This medication is indicated for treating eczema, a skin condition that causes red, irritated, and itchy skin.
According to IQVIA data, Fluocinolone Acetonide Oil had estimated annual sales of $10 million in the US in the 12 months to June 2023.
Recent USFDA approvals for Lupin
Earlier this month, Lupin announced that it received clearance from the US drug regulator for a new drug application for fluocinolone acetonide topical scalp oil.
Last month, the drug maker stated that its US-based subsidiary clearance from USFDA for abbreviated new drug application (ANDA) for chlorpromazine hydrochloride tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg, which is used in treating mental and mood disorders.
Also, it received the USFDA green signal for ANDA of cyanocobalamin nasal spray, 500 mcg/spray in July.
On Monday, the drug maker's subsidiary Lupin Digital Health (LDH) announced the launch of its newest offering, LyfeTM, a digital heart failure clinic in India.
This e-clinic aims to assist cardiologists and caregivers manage heart failure patients effectively from the comfort of their homes.
Mumbai-headquartered Lupin develops and commercialises a wide range of branded and generic drugs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific, Latin America, Europe, and Middle East regions.
It has 15 manufacturing sites, 7 research centers, and more than 20,000 professionals working across the world.
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